Senior Manager
3 weeks ago
We are seeking a highly skilled Senior Manager to join our team at MAC Clinical Research. As a Senior Manager, you will be responsible for leading and delivering comprehensive production services, including aseptic services, and ensuring compliance with Good Manufacturing Practice (GMP) regulations.
Key Responsibilities:- Lead and deliver comprehensive production services, including aseptic services
- Ensure compliance with GMP regulations
- Train production staff
- Liaise with staff, sponsors, vendors, and customers regarding requirements for studies of Investigational Medicinal Product (IMP) / commercial and comparator
- Ensure that products are produced and stored according to the appropriate documentation so that they reach the appropriate standards of quality
- Approving the instructions relating to production operations and ensure their strict implementation
- Ensure that the production records are evaluated and signed by an authorised person before they are sent to Quality Control (QC) Department
- Ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need
- The monitoring and control of the manufacturing environment
- Ensure plant hygiene standards are maintained
- The approval and monitoring of suppliers of materials
- The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activates
- The designation and monitoring of storage condition of materials and products
- The monitoring of compliance with the requirements of good manufacturing practice
- The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
- Participation in management reviews of processes performance, product quality and of the quality management system and advocating continual improvement
- Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
- Compliance with MAC health and Safety policy
- Compliance with MAC policy on equality and diversity
- To maintain professional qualifications required for the role, including continuous personal development
- To work according to MAC SOPs, guidelines and policies
- To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business related data.
- Required to travel to individual MAC Research sites as appropriate for training, equipment issues and client visits
- Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
- Health Insurance
- Free onsite parking
- 25 days annual leave (increasing in increments to 30 days after 6 years' service)
- Your birthday off work
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